NCT00809887

Micafungin Lock Therapy

Micafungin Lock Therapy to Clear Fungemia While Attempting to Preserve Central Venous Catheters

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

The study proposes to investigate, in children admitted at Children's Medical Center at Dallas, the effectiveness of antimicrobial lock therapy (ALT) with Micafungin in combination with systemic antifungal therapy in catheter-related fungal infections in order to salvage highly needed central venous catheter (CVC) and at the same time to investigate the effectiveness of Micafungin alone as systemic therapy in the treatment of Candidemia in a pediatric population.

Detailed description

The antimicrobial lock therapy (ALT) consists of filling a catheter lumen with a supraphysiologic concentration (100- to 1000- fold higher) of an antimicrobial agent and allowing it to dwell (lock) for several hours in an attempt to sterilize the lumen. Advantages of the ALT are: the ability to administer high local concentrations; the ease of administration; the cost-savings and vein access-savings by decreasing the number of surgical procedures in an operating room for catheter replacement; the decrease in possible surgical complications and risks. The Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America and others recommend the ALT for the treatment of uncomplicated bacteremias. This technique however is not currently recommended for the treatment of catheter-related fungal infections, primarily due to lack of adequate data. This study plans to enroll approximately 20 children admitted to the Children's Medical Center at Dallas in high need of central venous catheters or with evidence of fungemia in this study to investigate the effectiveness of ALT with Micafungin against fungal infections.

Conditions

• Catheter-Related Fungal Infections

Interventions

Type	Name	Description
DRUG	Micafungin lock therapy

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-06-01
• Completion: 2008-11-01
• First posted: 2008-12-17
• Last updated: 2008-12-17

Locations

1 site across 1 country: United States